Low-Dose Prednisone or Methylprednisolone in Treating Pat... | NCT00929695

ID	Type	Description	Link
NCI-2010-00323	Registry Identifier	CTRP (Clinical Trial Reporting Program)
P01CA018029	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm I (Low-dose)	Experimental	Patients receive low-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.	Drug: prednisone Drug: methylprednisolone Other: questionnaire administration
Arm II (Standard-dose)	Active Comparator	Patients receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.	Drug: prednisone Drug: methylprednisolone Other: questionnaire administration

Name	Type	Description	Arm Group Labels	Other Names
prednisone	Drug	immunosuppressive drug	Arm I (Low-dose) Arm II (Standard-dose)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment	The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42.	At day 42 after initiation of treatment

Secondary Outcomes

Measure	Description	Time Frame
Prednisone-associated Toxicity as Assessed by Hyperglycemia	Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone.	Baseline and then through 42 days after starting treatment
Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)

Eligibility Module

Name	Affiliation	Role
Marco Mielcarek	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium		Seattle	Washington	98109	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
FG001	Group B (Standard-dose)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
BG001	Group B (Standard-dose)	Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00073 BG00177 BG002150

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment

The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42.

From a total enrollment of 164 patients, the cumulative dose of prednisone at day 42 of treatment was available in 152 patients. The primary outcome was not measured in 12 patients due to withdrawal from study (2), discharge from Center before day 42 of treatment (10). Analysis was not completed in two patients due to an error in stratification.

Posted

Mean

Standard Deviation

milligrams per kilogram

At day 42 after initiation of treatment

ID	Title	Description
OG000	Grade IIa GVHD; 0.5 mg/kg/d Prednisone	Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
OG001	Grade IIa GVHD; 1.0 mg/kg/d Prednisone	Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
OG002	Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone	Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
OG003	Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone	Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.

Units	Counts
Participants	OG00044 OG00147 OG00229 OG003

Title

Denominators

Categories

Title	Measurements
	OG00022.2± 13.7 OG00127.1± 12.7 OG00238.4± 14.1 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		0.08						2-Sided								Superiority or Other
OG002 OG003		t-test, 2 sided		0.4

Secondary

Prednisone-associated Toxicity as Assessed by Hyperglycemia

Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone.

Posted

Mean

Standard Error

mg/dL

Baseline and then through 42 days after starting treatment

ID	Title	Description
OG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
OG001	Group B (Standard-dose)	Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.

Units	Counts
Participants	OG000

Secondary

Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)

The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected.

Posted

Number

percentage of participants

Baseline and through 100 days of treatment

ID	Title	Description
OG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
OG001	Group B (Standard-dose)	Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone

Units	Counts
Participants	OG000

Secondary

Prednisone-associated Toxicity as Assessed by Myopathy

Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position.

Posted

Mean

Full Range

units on a scale

Baseline and then weekly until 42 days after starting treatment

ID	Title	Description
OG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
OG001	Group B (Standard-dose)	Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.

Units	Counts

Secondary

Prednisone-associated Toxicity as Assessed by Hypertension

The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured.

Posted

Mean

Full Range

medications

Baseline and then through 42 days after starting treatment

ID	Title	Description
OG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
OG001	Group B (Standard-dose)	Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone

Units	Counts
Participants	OG000

Secondary

Prednisone-associated Toxicity as Assessed by Quality of Life

Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured.

Posted

Mean

Full Range

units on a scale

Baseline and then every other week until 42 days after starting treatment

ID	Title	Description
OG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
OG001	Group B (Standard-dose)	Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone

Secondary

Non-relapse Mortality

Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression.

Posted

Number

percentage of participants

At 12 months after the start of prednisone therapy

ID	Title	Description
OG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
OG001	Group B (Standard-dose)	Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone

Units	Counts
Participants	OG000

Secondary

Recurrent or Progressive Malignancy

Percentage of relapse estimated by cumulative incidence methods

Posted

Number

percentage of participants

At 12 months after the start of prednisone therapy

ID	Title	Description
OG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
OG001	Group B (Standard-dose)	Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone

Units	Counts
Participants	OG000

Secondary

Progression to Grade III-IV Acute GVHD

Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods.

Posted

Number

percentage of participants

At approximately 100 days after transplant

ID	Title	Description
OG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
OG001	Group B (Standard-dose)	Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone

Units	Counts
Participants	OG000

Secondary

Secondary Therapy for Acute GVHD Beyond Prednisone

This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods.

Posted

Number

percentage of participants

At approximately 100 days after transplant

ID	Title	Description
OG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
OG001	Group B (Standard-dose)	Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone

Secondary

Chronic Extensive GVHD

Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods

Posted

Number

percentage of participants

At 12 months after the start of prednisone therapy

ID	Title	Description
OG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
OG001	Group B (Standard-dose)	Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone

Units	Counts
Participants	OG000

Secondary

Overall Survival

Percentage of patients surviving as estimated by Kaplan-Meier.

Posted

Number

percentage of participants

At 12 months after the start of prednisone therapy

ID	Title	Description
OG000	Group A (Low-dose)	Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
OG001	Group B (Standard-dose)	Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm I (Low-dose)	Patients receive low-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity. prednisone: immunosuppressive drug methylprednisolone: immunosuppressive drug questionnaire administration: Ancillary studies			38	81	0	0
EG001	Arm II (Standard-dose)	Patients receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity. prednisone: immunosuppressive drug methylprednisolone: immunosuppressive drug questionnaire administration: Ancillary studies			30	83	0	0

Serious Adverse Events

Term	Organ System	Statistical Information
abdominal pain	Gastrointestinal disorders	EG0001 events1 affected81 at risk EG0011 events1 affected83 at risk
peripheral edema	Cardiac disorders	EG0000 events0 affected81 at risk EG0011 events1 affected83 at risk
palpitations	Cardiac disorders	EG0001 events1 affected81 at risk EG0010 events0 affected83 at risk
graft versus host disease	Immune system disorders	EG0009 events8 affected81 at risk EG0010 events0 affected83 at risk
lethargy	Nervous system disorders	EG0000 events0 affected81 at risk EG0011 events1 affected83 at risk
fever/infection	Infections and infestations	EG00014 events13 affected81 at risk EG00113 events11 affected83 at risk
orthostatic hypotension	Cardiac disorders	EG0001 events1 affected81 at risk EG0010 events0 affected83 at risk
gastroesophageal relux disease	Gastrointestinal disorders	EG0001 events1 affected81 at risk EG0010 events0 affected83 at risk
platelet infusion reaction	Blood and lymphatic system disorders	EG0000 events0 affected81 at risk EG0011 events1 affected83 at risk
relapse of hematological disease	Blood and lymphatic system disorders	EG0001 events1 affected81 at risk EG0014 events4 affected83 at risk
suicide	Social circumstances	EG0001 events1 affected81 at risk EG0010 events0 affected83 at risk
adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected81 at risk EG0011 events1 affected83 at risk
temporomandibular joint disorder	Musculoskeletal and connective tissue disorders	EG0001 events1 affected81 at risk EG0010 events0 affected83 at risk
chest pain	Cardiac disorders	EG0003 events1 affected81 at risk EG0011 events1 affected83 at risk
parotitis	Skin and subcutaneous tissue disorders	EG0001 events1 affected81 at risk EG0010 events0 affected83 at risk
mental status changes	Nervous system disorders	EG0001 events1 affected81 at risk EG0012 events2 affected83 at risk
hematopoietic graft failure	Blood and lymphatic system disorders	EG0000 events0 affected81 at risk EG0011 events1 affected83 at risk
congestive heart failure	Cardiac disorders	EG0001 events1 affected81 at risk EG0010 events0 affected83 at risk
atrial fibrillation	Cardiac disorders	EG0000 events0 affected81 at risk EG0011 events1 affected83 at risk
splenomagaly	Gastrointestinal disorders	EG0000 events0 affected81 at risk EG0011 events1 affected83 at risk
hypoxemia	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected81 at risk EG0010 events0 affected83 at risk
elevated liver function tests	Hepatobiliary disorders	EG0001 events1 affected81 at risk EG0010 events0 affected83 at risk
hypertension	Cardiac disorders	EG0000 events0 affected81 at risk EG0011 events1 affected83 at risk
leg pain	Musculoskeletal and connective tissue disorders	EG0000 events0 affected81 at risk EG0011 events1 affected83 at risk
nausea/vomiting	Gastrointestinal disorders	EG0001 events1 affected81 at risk EG0011 events1 affected83 at risk
diffuse alveolar hemorrhage	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected81 at risk EG0011 events1 affected83 at risk
trauma/fall	General disorders	EG0001 events1 affected81 at risk EG0010 events0 affected83 at risk
weakness	Musculoskeletal and connective tissue disorders	EG0001 events1 affected81 at risk EG0010 events0 affected83 at risk
colonic pneumatosis	Gastrointestinal disorders	EG0001 events1 affected81 at risk EG0010 events0 affected83 at risk

ID	Term
D006086	Graft vs Host Disease
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

ID	Term
D007154	Immune System Diseases
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders

ID	Term
D011241	Prednisone
D008775	Methylprednisolone
D000077555	Methylprednisolone Acetate
D008776	Methylprednisolone Hemisuccinate

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011239	Prednisolone
D011246	Pregnadienetriols